Use of Nitrous Oxide for Pain and Anxiety Management During Cervical Cerclage Removal

Summary

The goal of this clinical trial is to determine whether inhaled nitrous oxide can reduce pain and anxiety during cervical cerclage removal compared with standard care. Cervical cerclage removal is commonly performed in the outpatient setting during the third trimester of pregnancy and may be associated with discomfort and anxiety despite being a brief procedure.

The study will include pregnant women aged 18 years or older undergoing elective cervical cerclage removal at 36 weeks of gestation or later.

The main questions the study aims to answer are:

* Does inhaled nitrous oxide reduce pain during cervical cerclage removal?
* Does inhaled nitrous oxide reduce anxiety during the procedure?
* Does the use of nitrous oxide improve overall patient satisfaction during cerclage removal?

Researchers will compare women receiving inhaled nitrous oxide to those receiving standard care without analgesia, as routinely practiced in the participating institutions, in order to determine whether nitrous oxide improves pain control and patient experience during the procedure.

Participants will:

* Be randomly assigned to receive either inhaled nitrous oxide (50% nitrous oxide / 50% oxygen) or standard care without analgesic treatment during cervical cerclage removal.
* Undergo the procedure according to routine clinical practice in the participating centers.
* Complete questionnaires assessing pain and anxiety, including a visual analog scale (VAS) for pain and the State-Trait Anxiety Inventory (STAI).
* Have routine clinical data recorded from their medical records, including maternal vital signs and any procedure-related side effects.

Conditions

• Preterm Delivery
• Cervical Cerclage
• Cervical Insufficiency

Interventions

DRUG

Inhaled nitrous oxide

Inhaled nitrous oxide (50% nitrous oxide / 50% oxygen) administered via a demand-valve mask during cervical cerclage removal. The system includes a one-way valve and is self-administered by the patient, who holds the mask and inhales as needed. The device is identical to the equipment routinely used for labor analgesia in the participating institutions and is operated and monitored by trained midwives experienced in nitrous oxide administration. Nitrous oxide inhalation begins following instruction from the performing physician. The procedure starts approximately three minutes after inhalation begins, once adequate analgesia and anxiolysis are achieved. Continuous pulse oximetry monitoring is performed during administration. After completion of the procedure, nitrous oxide is discontinued and the patient breathes room air.

Sponsors & Collaborators

• Clalit Health Services

  collaborator OTHER

• Wolfson Medical Center

  collaborator OTHER_GOV

• Rabin Medical Center

  collaborator OTHER

• Meir Medical Center

  collaborator OTHER

• Kaplan Medical Center

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-05-01

Primary Completion

2028-05-01

Completion

2028-05-01

Countries

• Israel

Study Locations